Application 203314

Type: BLA
Sponsor: NOVO

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
203314	Tresiba	insulin degludec	351(a)	Rx	2026-07-01

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRESIBA	INSULIN DEGLUDEC	SOLUTION;SUBCUTANEOUS	300 UNITS/3ML (100 UNITS/ML)	No	No
002	TRESIBA	INSULIN DEGLUDEC	SOLUTION;SUBCUTANEOUS	600 UNITS/3ML (200 UNITS/ML)	No	No
003	TRESIBA	INSULIN DEGLUDEC	SOLUTION;SUBCUTANEOUS	1000 UNITS/10ML (100 UNITS/ML)	No	No

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Insulin Degludec	INSULIN DEGLUDEC	A-S Medication Solutions	7a4bd8e5-7af4-4573-97c2-9945faf6a7dd	2024-06-03	Warnings, Adverse reactions	Exact identifier application number: BLA203314
Insulin Degludec	INSULIN DEGLUDEC	A-S Medication Solutions	62128c8b-f613-44d9-af04-18d52c4348cd	2024-05-31	Warnings, Adverse reactions	Exact identifier application number: BLA203314
TRESIBA	INSULIN DEGLUDEC	A-S Medication Solutions	e8ccd2f4-6ba9-4839-87f8-4742dc9b1c17	2024-02-22	Warnings, Adverse reactions	Exact identifier application number: BLA203314
Tresiba	INSULIN DEGLUDEC	A-S Medication Solutions	84197351-cb71-4282-8217-13103404a2b4	2023-12-12	Warnings, Adverse reactions	Exact identifier application number: BLA203314 ndc (product): 50090-3491
Insulin Degludec	INSULIN DEGLUDEC	Novo Nordisk Pharma, Inc.	c1be283d-4b1d-4996-b2a7-4488dbff3037	2022-07-01	Warnings, Adverse reactions	Exact identifier application number: BLA203314 ndc (product): 73070-403 ndc (product): 73070-503 ndc (product): 73070-400
Tresiba	INSULIN DEGLUDEC	Novo Nordisk	456c5e87-3dfd-46fa-8ac0-c6128d4c97c6	2022-07-01	Warnings, Adverse reactions	Exact identifier application number: BLA203314 ndc (product): 0169-2660 ndc (product): 0169-2550 ndc (product): 0169-2662

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0169-2550	Tresiba	insulin degludec injection	Novo Nordisk	BLA	Current
0169-2550	Tresiba	insulin degludec injection	Novo Nordisk	NDA	Current
0169-2550	Tresiba	insulin degludec injection	Novo Nordisk	NDA	Current
0169-2550	Tresiba	insulin degludec	Novo Nordisk	BLA	Current
0169-2660	Tresiba	insulin degludec injection	Novo Nordisk	BLA	Current
0169-2660	Tresiba	insulin degludec injection	Novo Nordisk	NDA	Current
0169-2660	Tresiba	insulin degludec injection	Novo Nordisk	NDA	Current
0169-2660	Tresiba	insulin degludec	Novo Nordisk	BLA	Current
0169-2662	Tresiba	insulin degludec injection	Novo Nordisk	BLA	Current
0169-2662	Tresiba	insulin degludec injection	Novo Nordisk	NDA	Current
0169-2662	Tresiba	insulin degludec injection	Novo Nordisk	NDA	Current
0169-2662	Tresiba	insulin degludec	Novo Nordisk	BLA	Current
50090-3491	Tresiba	insulin degludec	A-S Medication Solutions	BLA	Current
50090-3491	Tresiba	insulin degludec	A-S Medication Solutions	NDA	Current
50090-3491	Tresiba	insulin degludec	A-S Medication Solutions	BLA	Current
50090-3491	Tresiba	insulin degludec	A-S Medication Solutions	NDA	Current
73070-400	Insulin Degludec	insulin degludec	Novo Nordisk Pharma, Inc.	BLA	Current
73070-403	Insulin Degludec	insulin degludec	Novo Nordisk Pharma, Inc.	BLA	Current
73070-503	Insulin Degludec	insulin degludec	Novo Nordisk Pharma, Inc.	BLA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71512	SUPPL	2022-07-05
71511	SUPPL	2022-07-05
71510	SUPPL	2022-07-05
71509	SUPPL	2022-07-05
62408	APPL	2020-04-01
60956	SUPPL	2020-03-23
60955	SUPPL	2020-03-23
60895	SUPPL	2020-03-23
60894	SUPPL	2020-03-23
56721	SUPPL	2020-03-23
56554	SUPPL	2020-03-23
55157	SUPPL	2020-03-23
55149	SUPPL	2020-03-23
53508	SUPPL	2020-03-23
53462	SUPPL	2020-03-23
51188	ORIG	2020-03-23
51186	ORIG	2020-03-23
51183	ORIG	2020-03-23
51182	ORIG	2020-03-23
46475	SUPPL	2020-03-23
46234	SUPPL	2020-03-23
43427	ORIG	2020-03-23
19454	ORIG	2020-03-23
10195	ORIG	2020-03-23
62329	SUPPL	2018-03-26
64939	ORIG	1900-01-01
63076	ORIG	1900-01-01
63075	ORIG	1900-01-01